Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

Timeline

Start

2006-09-11

Primary completion

2008-11-25

Completion

2008-11-25

Outcome

Missed primary endpoint

registry Mepolizumab 0.55 mg/kg vs Mepolizumab 2.5 mg/kg; p = 0.865; Odds Ratio (OR) 0.55 (95% CI 0.04 to 5.44); Regression, Logistic NCT00358449 ↗

registry Mepolizumab 0.55 mg/kg vs Mepolizumab 10 mg/kg; p = 0.190; Odds Ratio (OR) 0.21 (95% CI 0.01 to 2.07); Regression, Logistic NCT00358449 ↗

Publications

• Background Assa'ad AH, Gupta SK, Collins MH, Thomson M, Heath AT, Smith DA, Perschy TL, Jurgensen CH, Ortega HG, Aceves SS. An antibody against IL-5 reduces numbers of esophageal intraepithelial eosinophils in children with eosinophilic esophagitis. Gastroenterology. 2011 Nov;141(5):1593-604. doi: 10.1053/j.gastro.2011.07.044. Epub 2011 Aug 9.
• Wong ECL, Gleave AL, Marshall JK, Narula N. Predictors of histologic response to mepolizumab in pediatric eosinophilic esophagitis. Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1131-1136. doi: 10.1097/MEG.0000000000002623. Epub 2023 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mepolizumab	Monoclonal antibody	0.55 mg/kg	Intravenous
Subject	Mepolizumab	Monoclonal antibody	2.5 mg/kg	Intravenous
Subject	Mepolizumab	Monoclonal antibody	10 mg/kg	Intravenous

Indications